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news.Dendreon Corporation's Provenge, in combination with Genentech's Avastin, has been shown to have a biologic effect in patients with biochemically-relapsed prostate cancer in a phase II study.
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In the study, known as the P-16 study, 22 patients with androgen-dependent prostate cancer, who had undergone prior definitive surgical or radiation therapy, were enrolled and treated.
Provenge was given intravenously (IV) on weeks one, two and four. Patients were given 10mg/kg of IV Avastin (bevacizumab) immediately following Provenge and continued every two weeks thereafter until disease progression or toxicity was observed.
The median pre-treatment PSA doubling time (PSADT, a measure of prostate cancer disease biology) for the 21 evaluable patients was 6.7 months, and the median on-treatment PSADT was 12.7 months, an approximate 90% increase in PSADT.
Eight patients displayed at least a 200% increase in PSADT while on study compared with their pretreatment rate of change. In addition, 41% of patients exhibited a decrease in their absolute PSA value from baseline.
No patient on study had objective disease progression but four patients were removed from the study due to toxicity (congestive heart failure, hypertension, cerebrovascular ischemia and proteinuria).
“These results provide encouraging proof-of-concept that Provenge can be safely combined and work synergistically with other immune-modulating therapies such as Avastin for the treatment of men with prostate cancer,” said Dr Brian Rini, assistant professor of medicine at the University of California, San Francisco. “The alteration in PSADT seen in this trial may reflect the biologic effect of this combination therapy.”